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| Name | Class |
|---|---|
| Hospital de Nens de Barcelona | OTHER |
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Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both mandibular 3rd molars. Patients were assessed for surgery-derived complications in a follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and eating difficulty in a patient diary.
This was a single-centre, prospective, double-blind, randomized, placebo-controlled, parallel-group study to evaluate whether probiotic supplementation during 1 week after surgery reduced post-surgery complications compared to placebo.
Healthy subjects of both genders aged between 14 and 25 years who required the surgical removal of both mandibular 3rd molars were recruited from the department of Oral and Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital of Barcelona).
Patients were randomly assigned to receive probiotic tablets containing a mixture of L. plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice a day for 7 days post surgery.
Patients were assessed by trained specialists for surgery-derived complications (fever, oral alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients also provided daily evaluations for pain, swelling and eating difficulties in a patient diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Orodispersible tablets containing AB-DENTALAC probiotic formula. |
|
| Control | Placebo Comparator | Orodispersible tablets without probiotic strains (excipients only). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic AB-DENTALAC | Dietary Supplement | Orodispersible tablets containing Lactobacillus plantarum [now Lactoplantibacillus plantarum] KABP051 (CECT7481) and Lactobacillus brevis [now Levilactobacillus brevis] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications derived from surgical removal of both mandibular third molars | Occurrence of low grade fever (Yes/No), oral alveolitis (Yes/No) and/or trismus (Yes/No), as determined by a trained specialist | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical pain, patient-rated | Oral pain derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. | Daily, for 7 days |
| Post-surgical swelling, patient-rated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduard Ferres Padro, MD | Children's Hospital of Barcelona | Principal Investigator |
| Jordi Espadaler Mazo, PhD | AB Biotics, SA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Nens de Barcelona (Children's Hospital of Barcelona)) | Barcelona | 08009 | Spain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Probiotic and placebo tablets with identical appearance were provided in anonymous packages to the investigators, solely labelled with the volunteer's randomization number
|
| Placebo | Other | Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days. |
|
| Surgical removal of mandibular third molars at baseline | Procedure | Surgical removal of both mandibular third molars, performed under intravenous sedation and loco-regional anesthesia (Articaine Hydrochloride 4% with Epinephrine 1:100.000), after having undergone a professional oral cleaning. |
|
| Ibuprofen | Drug | Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days |
|
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Mandibular swelling derived from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary.
| Daily, for 7 days |
| Post-surgical eating difficulty, patient-rated | Eating difficulty as a result from surgery, rated 0 (none) to 10 (unbearable) in a Visual Analog Scale (VAS) in a patient diary. | Daily, for 7 days |